Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business
CSL SEQIRUS
Mexico
Hybrid
Local regulatory requirements
Health authority national engagements
New product registration
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico branch, focusing on regulatory affairs and pharmacovigilance for biological and biotechnological products. The role involves managing product registrations, lifecycle maintenance, and ensuring compliance with local health authority requirements. The position offers a hybrid work model and is ideal for candidates with extensive regulatory experience and relevant educational backgrounds
Job Summary
You will be responsible for new product registration, product lifecycle maintenance (variations, renewals), obtaining import licenses and local product batch release.
You will also manage the evaluation of advertising materials and mainly focus on biological, biotechnological, and orphan drug products.
This is a hybrid role, which offers a combination of an onsite and remote work schedule.
Matching Summary
Match Score: 85
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico branch, focusing on regulatory affairs and pharmacovigilance for biological and biotechnological products. The role involves managing product registrations, lifecycle maintenance, and ensuring compliance with local health authority requirements. The position offers a hybrid work model and is ideal for candidates with extensive regulatory experience and relevant educational backgrounds.
Skills & Requirements
Must-have
local regulatory requirements
Health Authority national engagements
new product registration
product lifecycle maintenance
obtaining import licenses
local product batch release
evaluation of advertising materials
biological, biotechnological, and orphan drug products
Nice-to-have
stay updated on local regulatory requirements
monitor and report progress consistently
work effectively both independently and in a team
Key Requirements
5+ years of professional experience in local regulatory affairs
Bachelor’s, Master’s, or equivalent degree in life-sciences
Expertise in local health authority systems i.e., DIGIPRIS, VUCEM
Required fluency in Spanish and English, oral and written